Details for New Drug Application (NDA): 040288
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NDA 040288 describes ZYDONE, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. Additional details are available on the ZYDONE profile page.
The generic ingredient in ZYDONE is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
The generic ingredient in ZYDONE is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040288
| Tradename: | ZYDONE |
| Applicant: | Vintage Pharms Llc |
| Ingredient: | acetaminophen; hydrocodone bitartrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG;5MG | ||||
| Approval Date: | Nov 27, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG;7.5MG | ||||
| Approval Date: | Nov 27, 1998 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG;10MG | ||||
| Approval Date: | Nov 27, 1998 | TE: | RLD: | No | |||||
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